Akeso has received clearance from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) to begin a Phase I trial of AK158D1, an investigational bispecific antibody-drug conjugate (ADC), for patients with advanced malignant solid tumours.

AK158D1 aims to target both epidermal growth factor receptor (EGFR) and trophoblast cell surface antigen 2 (TROP2), two proteins frequently co-expressed in a range of solid tumours.

This development marks the fourth ADC from Akeso to reach the clinical stage, with previous candidates that comprise AK146D1, AK138D1, and AK157D1.

EGFR and TROP2 targets have recognised roles in anti-tumour response, and dual targeting has been identified as having the potential for a synergistic effect.

Current single-target ADCs aimed at EGFR or TROP2 have faced challenges such as limited tumour coverage, off-target toxicity, and multidrug resistance.

The dual-targeting structure of AK158D1 uses bispecific antibody technology and is formulated to provide targeted anti-tumour activity alongside a cytotoxic payload and an improved safety profile.

Preclinical studies have shown anti-tumour activity and a favourable safety profile.

Akeso continues to develop its bispecific antibody and ADC pipeline, including agents such as ivonescimab and cadonilimab, which are being evaluated in combination with ADC candidates.

Two bispecific antibodies from Akeso are currently approved for use in cancer treatment.

The company also has a portfolio of more than 50 assets across therapeutic areas such as cancer, inflammation, autoimmune diseases and metabolic disorders.

Akeso maintains a range of research and development platforms and eight commercially available drugs, with additional candidates under regulatory review.

Earlier this month, Akeso and Summit Therapeutics’ ivonescimab showed further benefit in a first-line non-small cell lung cancer (NSCLC) Phase III study, meeting the key secondary overall survival (OS) endpoint.